High-Dose Chemoradiotherapy With Stem Cell Support in Patients With Relapsed or Refractory Hodgkin's Disease
OBJECTIVES: I. Determine the toxicity and response to high dose chemotherapy and peripheral
blood stem cell support in patients with recurrent or refractory Hodgkin's disease. II.
Determine the maximum tolerated dose of etoposide when combined with carboplatin and
cyclophosphamide in these patients.
OUTLINE: This is a dose escalation study of etoposide. Patients undergo total nodal
radiotherapy twice a day on days -35 to -31, -28 to -24, and then radiotherapy boost once a
day on days -21 to -17. Patients then receive etoposide IV continuously and carboplatin IV
continuously on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
Autologous peripheral blood stem cells are infused on day 0. Patients who have received
prior extensive radiation (at least 2000 cGy to any site) only receive chemotherapy and
peripheral blood stem cell infusion. Cohorts of 4-8 patients receive escalating doses of
etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose at which 1 of 4 or 2 of 8 patients experience dose limiting toxicity. Patients are
followed every 1-3 months for 2 years, then every 3 months until death.
PROJECTED ACCRUAL: At least 4 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Leo I. Gordon, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Federal Government
NU 93H2
NCT00004169
November 1993
January 2007
Name | Location |
---|---|
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |